Toxicological Studies on Philippine Natural Grade Carrageenan

Quintin L Kintanar, Clara Y. Li -Sylianco, Oscar G. Gutierrez, Jr., Helen A. Molina, Ofelia M. Alba, Carlito J. Calderon, Evangeline P. Pagsanhan, J. Balboa, E. Serrame, E. Guantes, Erwina G. De Castro, Caroline Imelda B. Biares, Edgar L. Calbitaza, Yoshiaki Saitoh, and Kiyoshi lmai
Bureau of Food and Drugs, Department of Health
Institute of Chemistry, University of the Philippines
College of Veterinary Medicine, University of the Philippines Los Baños
Hatano Research Institute, Food and Drug Safety Center Hadano, Japan

doi.org/10.57043/transnastphl.1997.5936

Abstract

PNG carrageenan, a new class of food additive derived from Eucheuma cottonii and E. spinosum seaweeds, has been globally marketed since 1980. To prove that it is non-toxic and to earn the recognition of the Food Codex Alimentarius and the FAO/WHO Joint Expert Committee on Food Additive (JECFA) as a food additive and, thereby, eliminate future international trade barriers, several toxicological studies were carried out using the conventionally processed (CP) carrageenan as the positive control. A three-month subchronic toxicity test was carried out in rats to examine the adverse effects over a period of time and the cumulative toxicity on target organs and on physiologic and metabolic tolerance from repeated exposure. The following parameters were observed: general observation, body weight, feed efficiency, intake of test materials, clinical examinations (hematology, serum biochemistry, blood coagulation analysis, urinalysis, and fecalysis), and gross, light microscopic and TEM examinations of tissues and organs. A battery of genotoxicology tests, namely Rec assay to determine direct DNA damaging potential, Ames test to assess the mutagenic potential before metabolic activation, Host-mediated assay to determine the mutagenicity after metabolic activation, Micronucleus test to investigate the chromosome breaking effect as well as antigenotoxic activities were done. The subchronic toxicity test in rats revealed the following findings: 1. There were no toxic manifestations or adverse effects observed with PNG and CP carrageenan in rats at a dose that is 80 times more than the Acceptable Daily Intake (ADI) set by the FAO/WHO JECFA for CP carrageenan 2. There was no evidence that PNG and CP carrageenan absorbed from the GIT.

The genotoxicity tests showed that PNG and CP carrageenan 1. do not possess any direct DNA damaging potential, 2. are not mutagenic before and after metabolic activation, 3. have no chromosome breaking effects, and 4. reduced the chromosome breaking effects of the three known genotoxins. From all the studies that were done, it can be concluded that PNG carrageenan has the same toxicological attributes as CP carrageenan and does not present any food safety concern. An ADI for PNG carrageenan, similar to CP carrageenan, can be assigned by the FAO/WHO JECFA. So far in the past years, the Philippine Government has made several significant success in its campaign for PNG carrageenan’s international recognition as a food additive and they are as follows: 1. In 1995, the Food Codex Alimentarius, Codex Committee on Food Additives and Contaminants, granted PNG carrageenan a Code No. E 407a under the International Numbering System, 2. In 1996, the European Union lifted the ban on PNG carrageenan as a food additive and allowed its entry in the European Single Market. 3. In 1994, the FAO/WHO JECFA required additional data on PNG carrageenan and calendared it for another round of review in their 1998 meeting to assign a final ADI. Consequently, the new status of PNG carrageenan triggered significant growth in the carrageenan industry in terms of strengthening the economy of the Philippines, expansion of the carrageenan market, improvement of technology and employment security to the marginalized fisherfolks of the Southern and Central Philippines. The seaweed is now one of the nation’s 14 top export industries. The industry’s total export in 1996 reached US 120 million compared to only about US 16 million in 1990, 750% increase.